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EU data protection legislation

Personal data, such as individual patient records, provide a vital resource for research for the benefit of society and saving and improving the lives of patients.

Proposals for an EU Data Protection Regulation

In 2012, the European Commission proposed a comprehensive reform of data protection rules that would harmonise across EU member states the laws governing the use of personal information. This draft Data Protection Regulation will affect how patient data are used in research, and so the MRC and stakeholders including the Wellcome Trust have been working together throughout the EU decision-making procedure, to ensure the implications for research were understood and that the new regulation facilitates research while protecting participants.

In December 2015, the European Commission, European Parliament and the Council of the European Union reached informal political agreement on the text of the Data Protection Regulation, and they are expected to formally agree it in the first half of 2016. Once formally agreed the Regulation will come into force within in two years. The MRC welcomes the current text, which includes important provisions to support research. We will continue to work with the UK Government and other stakeholders throughout the implementation stage to support research.

Background: Concerns around amendments adopted by the European Parliament

The MRC, along with other major European research organisations, welcomed the original text of the Regulations, which set out a mechanism for protecting privacy while enabling research. This included a requirement for specific and explicit consent for the use and storage of personal data, while providing an exemption for research, subject to strong ethical and governance safeguards.

However, in October 2013, the Civil Liberties and Home Affairs (LIBE) committee of the European Parliament adopted amendments that would have severely restricted the use of personal data for scientific research purposes without specific consent. The MRC’s concerns around the impact of these amendments were set out in a joint statement from non-commercial research organisations and academics, published in March 2014. In the currently agreed text of the Regulation, many of these identified areas of concern have been addressed.

Further information

Contact

For more information, please contact: Rosa Parker, Corporate Information and Policy Manager rosa.parker@headoffice.mrc.ac.uk